MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; MTS,3,PORT,RED,KIT-LEESBURG,REG MED CEN

Catalog Number	60122271
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025 the "device was being used to inject a contrast/saline mix to view coronary arteries during procedure and when physician let go of syringe after injection the syringe spun by itself in counterclockwise direction.".
Additional Manufacturer Narrative
It was reported that on (b)(6) 2025 the "device was being used to inject a contrast/saline mix to view coronary arteries during procedure and when physician let go of syringe after injection the syringe spun by itself in counterclockwise direction." the customer reported there were no visible defects noticed on the syringes.There was no report of any patient injury or adverse event.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Update to h6: investigation findings.Update to h6: investigation conclusions.

• Common Device Name: MTS,3,PORT,RED,KIT-LEESBURG,REG MED CEN
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 3864
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21548887
• Report Number: 3015910259-2025-00020
• Device Sequence Number: 11867137
• Product Code: OEZ
• UDI-Device Identifier: 10193489046144
• UDI-Public: 10193489046144
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 60122271
• Device Lot Number: 0000137496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 46 KG